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Friday, February 15, 2013

The Hip Replacement Case Shows Why Doctors Often Remain Silent

The doctor, who also worked as a consultant to Johnson & Johnson, wrote the note nearly two years before the company recalled the device in 2010. And it was far from the only early warning those executives got from doctors who were paid consultants. Still, the company’s DePuy orthopedic unit plowed ahead, and those consultants never sounded a public alarm to other doctors, who kept implanting the device.

The memos have recently emerged during the trial of the first of more than 10,000 patient lawsuits brought against Johnson & Johnson over the hip implant device, the Articular Surface Replacement, or A.S.R. The company has insisted that it acted responsibly in determining when to halt its sale. But plaintiffs’ lawyers have offered a portrait of executives who put profits ahead of patients, even scuttling a plan to fix the implant because it cost too much.

It might not be surprising to find that executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so.

“Questioning the status quo in medicine is not easy,” said Dr. Harlan Krumholz, a professor at Yale School of Medicine.

Physicians may remain silent for a variety of reasons, he and other experts said. They may fear that speaking out could get them sued or believe that a product problem was an anomaly or their fault.

Doctors also have an aversion to reporting. For instance, while the Food and Drug Administration relies on physicians to help monitor product safety by alerting the agency to adverse patient reactions, doctors usually do not make such filings, saying they are too busy for the paperwork.

“The standard in the medical community is not to report,” said Dr. Robert Hauser, a cardiologist who, along with a colleague, warned other doctors in 2005 about a defective heart implant.

There is another reason doctors may choose to remain silent, experts say: their financial ties to a drug or device maker.

For years, such consulting payments have raised concerns about the impact of money on a doctor’s decision about which drugs to prescribe or how to interpret research findings. Money can also shift a physician’s sense of loyalty, said George Loewenstein, a professor at Carnegie Mellon University who has studied medical conflict-of-interest policies. “If someone has been paying you or employing you, it is very difficult to blow the whistle,” said Professor Loewenstein, who teaches economics and psychology. “It offends our sense of loyalty.”

Dr. Krumholz said he also believed that such loyalties were between a doctor and a company’s executives, rather than with a company or its brand. Over time, a physician may come to see his relationships with those officials in terms of friendship, while companies see an influential doctor as an asset who helps develop products and boost sales.

For a consultant, breaking those ties can carry a cost. For example, when Dr. Lawrence D. Dorr, an orthopedic specialist, warned fellow surgeons in an open letter in 2008 that a hip implant made by Zimmer Holdings was flawed, he became the subject of a whisper campaign that questioned his skills as a surgeon.

“The first thing that a company does is to put out a campaign that a surgeon does not know how to operate,” said Dr. Dorr, who was a consultant to Zimmer when he wrote the letter. “It hurt my practice for a year.”

TRADITIONALLY, doctors have brought problems to the attention of colleagues by conducting research and publishing their findings in a medical journal. The advantage of that system helps ensure the credibility of study data and protects a researcher from random attack, said Dr. David Blumenthal, the president of the Commonwealth Fund, a group that studies health policy issues.

But getting a study published can take a year or two; some Johnson & Johnson consultants did publish studies about the hip’s flaws, but they largely appeared after it had been recalled.

Dr. Blumenthal said there was probably a need for more immediate ways for doctors to share their concerns, like forums supported by professional medical organizations. Another approach would be to have companies hire doctors as consultants whose sole concern was product safety, Professor Loewenstein said.

The results of not speaking out are playing out in a Los Angeles courtroom, where the first Johnson & Johnson hip case is unfolding. In the years before the implant’s recall, a British physician, Dr. Antoni Nargol, and a colleague were among those who tried to alert surgeons to the problem.

But the silence of other doctors apparently gave company executives the upper hand; in meetings with Dr. Nargol, they said that he seemed to be the only doctor having trouble.

He said recently, “They told me there were no other problems.”

Barry Meier is a reporter who covers business and medicine for The New York Times.

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The term "PR" means something completely different to a medical doctor!
"We are all born ignorant, but one must work hard to remain stupid." -Benjamin Franklin.
"It takes a wise doctor to know when not to prescribe."
- Gracian.